DE69530896T2 - DEVICE FOR PROMOTING SOFT TISSUE ENLARGEMENT AND Wounds Healing - Google Patents

Abstract

An apparatus and method for healing open wounds through enlargement of soft tissue surrounding said wound is comprised of a dome configured to fit over the wound and at least a portion of the surrounding soft tissue. The dome has a rim with a surface area equal to or greater than the normal area of the dome opening to prevent medical complications caused by excessive pressure to the skin. A gasket or other cushioning material may be provided about the periphery of the dome for patient comfort and improved seal. The dome also includes a vacuum pump with a power source, pressure sensor, and servomechanism for regulating the pressure within the dome to any one of several protocols using pressures which might temporarily exceed non-damaging levels.

Description

referral on related registration

This registration is a partial continuation registration application number 08 / 220,186, filed on March 30, 1994, now U.S. Patent No. 5,701,917, issued December 30, 1997.

Background of the Invention

There are numerous opportunities where people feel the need have to enlarge the soft tissue in their body. A such an opportunity is to replace one or both breasts during one Breast amputations were amputated to maintain physiological symmetry and restore psychological well-being. Other occasions are those used to correct congenital anomalies such as dimple formation. Other opportunities are to increase physical attributes, about beauty and self-esteem to improve. These latter soft tissue enlargements are mainly due to Breast augmentation at Women and penis enlargements in men directed.

They are prosthetic implants for insertion developed under the skin. The severity of the potential complications including Scarring, rupture of the implant, capsular contracture, necrosis and migration of the implant, as well as the most recent enemy However, publicity has made the appeal of these implants essential reduced. Hence there is a social need for others Means to enlarge soft tissue achieve.

Some soft tissue enlargements kick of course on. So enlarges for example during pregnancy over the skin the abdomen of a woman about nine times her original Area to the fetus without picking up a proportional decrease in skin thickness. With others Words, the abdominal skin tissue actually increases and doesn't just stretch during pregnancy. More like that Way the skin will stretch to any growth under the Skin.

In the past have plastic Surgeons this phenomenon used to their advantage to stretch skin to prosthetic implants take. The surgeon uses one to perform this procedure Balloon under the skin in the area where additional skin is desired. By gradually expanding the balloon, the skin initially stretches and grows indeed in certain circumstances, around the increased volume to take up among themselves. When the desired amount of skin is formed the balloon is deflated and removed, and the implant is removed in the back through the balloon left cavity inserted. Similar procedures have been used by indigenous African tribes to lips, nostrils and earlobes to enlarge.

Have other surgical techniques the tissue enlargement used to achieve other types of soft tissue growth. So for example, balloons are successful beneath nerves, veins, Tendons and the like have been enlarged to thereby lengthen these tissues, for damage to fix and alleviate various anomalies.

A more advanced surgical procedure is known as callotasis or limb extension. This method involves cutting open the bone around its circumference the place where an extension required is, leaving the inner tissue and that around the bone untouched becomes. There will be staples on each side of the cut on the bone attached, and the bone segments are slowly over one Period of several months moved away from each other Completely stay. This not only causes the healed bone to last longer but the soft tissue surrounding the bone actually grows, to accommodate the increased link length. Similar procedures have been used by indigenous African tribes to cosmetic necks To extend purposes.

Any of the devices and methods mentioned above require an invasive surgical technique to enlarge the soft tissue to reach. Invasive techniques increase the likelihood the one with the procedure including the above related complications related to implant surgery. About that In addition, the cost of surgery prevents many people from their abnormalities correct or upgrade physical properties.

Other soft tissue enlargement techniques have been developed that use other mechanisms to cause the enlargement. For example, an instrument and technique for non-surgical correction of nipples due to a short milk channel have been developed. The instrument consists of a cup with an internal volume that is shaped like the nipple you want. The user places the cup over the hollow nipple, pumps the air out of the cup with a syringe and sets the vacuum inside the cup using a control valve just below the discomfort limit. In this way, the device tightens the milk ducts and extends them sufficiently after two to three months of wearing 8th - 12 Hours a day.

Although this device is sufficient for its intended purpose, it is not suitable for general soft tissue enlargement. Lacerations and bruises can occur if one Excessive suction is applied to soft tissue. Because the pressure inside the nipple device is not regulated, bruises and lacerations can occur. When a vacuum is developed within the cup of the instrument, an equal and opposite force is applied across the rim of the cup to the patient. Excessive contact forces with the patient can cause ulcers, lacerations and bruises. Since the contact forces are not regulated in the nipple instrument, these further complications can also occur. In addition, a general soft tissue enlargement cannot be carried out with the instrument due to the size and shape of the cup.

Another prior art device is disclosed in US Patent No. 936,434 as a device for enlarging the female breast. This device includes a pair of cups for placement on the breasts and a pump to extract air between the cups and the breasts. However, this patent does not provide any teaching regarding the pressures to be used, the potential hazards to the skin tissues, or any suggestions on how to keep the device in place during use. Obviously, the device is used in a clinical setting and is not for long wear, such as for 8th - 10 Hours, suitable. Since the patent indicates that the vacuum acts to cause veins and arteries to become clogged, thereby nourishing the breasts, it is clear that the patentee claims that breast expansion actually causes the breast tissue to expand by this expansion alone , This patent was the subject of mockery by at least one medical authority. See "An Anthology Of Plastic Surgery," edited by Harry Hayes, Jr., MD, Section 6, "Quackery and Nostrums," published. 1986 by Aspen Publishers, Rockville, Maryland.

Finally, another device state of the art, although notoriously noteworthy, worth mentioning. This device is commonly referred to as and penis pump is primarily sold as a novelty, although its long-term enlargement effectiveness has never been proven and in reality generally by their suppliers is denied. The device consists of a cylinder an open end into which the penis is inserted and one at it attached pump that creates a vacuum in the cylinder can. Not only does this device have the same disadvantages as the nipple instrument has any complications, it is also unlikely to have a sufficient vacuum through it the device can be maintained to provide any long term soft tissue enlargement cause. Furthermore, the device is obviously designed to perform two tasks without reference to enlargement. First will used the device for stimulation and sexual satisfaction. Second, the device is used to pull in Blood in the penis to promote an erection.

There is also another fact which is routinely experienced by many patients with whom the formation of soft tissue is important. This fact arises from injuries or illnesses that cause wound infections or ulcers, that have a tendency to secrete body fluids and oppose healing. At least one try is so far is known to the inventors herein, in the prior art To address problem. This solution of the prior art the use of an occlusive or airtight dressing, covering the wound, associated with either a single or repeated suction of liquid out of the wound to dry it out and create an environment that is more conducive to wound healing is. It is not believed that this state of the art Problems of excessive contact forces against the patient's skin considered, the ulceration, Crack wounds and crushing caused. Furthermore, the teaching is this State of the art not due to enlargement of soft tissue directed the use of a vacuum alone, but concerns instead, at least partially using suction for the removal of wound fluid and creating an environment that promotes healing. The importance the enlargement of the surrounding soft tissue to close the wound is not clearly in the foreground this prior art method.

Most of these prior art devices and methods have been unable to achieve long-term soft tissue enlargement while preventing damage to the soft tissue to be enlarged as well as the surrounding tissue. The inventor herein has succeeded in designing and developing a new generalized method and device for soft tissue enlargement that prevents damage to the soft tissue. The device used for this enlargement consists of a rigid, liquid-tight dome with an edge along its circumference and a vacuum pump to reduce the pressure, thereby applying a pulling force to the soft tissue isolated through and within the dome. The edge has a sufficient surface area so that the pressure exerted on the patient by the edge is less than or equal to the negative pressure exerted on the tissue under the dome. In this way, as long as the pressure inside the dome is regulated to a limit below which no medical complications arise, the opposite contact pressure is set the patients are also below this threshold. This approach prevents damage not only to the soft tissue to be enlarged, but also to the surrounding tissue. In the preferred embodiment of the device, the vacuum pump has an independent power source. In addition, a pressure sensor and a servomechanism regulate the pump so that the vacuum inside the dome is kept to a size of less than 35 mm of mercury. Different embodiments can be designed to fit over and enlarge a human breast, penis, infected wound, sore, ulcer, or any other desired area.

The application process consists of the steps of attaching the dome to the desired location Enlargement, and creating a vacuum within the dome. The vacuum should maintained at least eight hours a day, and the Results should be sufficient after several months.

Although the practical advantages and Features of the present invention and method briefly above have been described can provide a better understanding of the new and unique Features of the invention by reference to the following drawings and the detailed description of the preferred embodiments be preserved.

Short description of the drawings

1 Fig. 4 is a front elevation view of the soft tissue enlargement device showing the breast enlargement embodiment;

2 FIG. 4 is a cross-sectional view of the breast augmentation embodiment in the plane of line 2-2 of FIG 1 ;

3 Figure 3 is a cross-sectional diagram of a dome and soft tissue in the early stages of enlargement;

4 Figure 3 is a cross-sectional diagram of a dome and soft tissue in the later stages of enlargement;

5 Figure 12 is a vertical projection of the penis enlargement embodiment of the present invention; and 6 Figure 3 is a partial cross-sectional view of a dome placed over an open wound.

Detailed description the preferred embodiment

The device 10 for enlarging soft tissue generally consists of a dome 12 with a border 14 and a vacuum pump device 16 to create a vacuum inside the dome. Although the vacuum pump device 16 In one embodiment variant, a separate portable pump can be the vacuum pump device 16 in the preferred embodiment, an independent vacuum pump 20 with an independent power source 22 , a pressure sensor 24 and a servomechanism 26 for driving, regulating and controlling the vacuum pump 20 ,

Regulation of the pressure inside the dome is essential to avoid bruises caused by capillary rupture near the surface of the skin that separate the epidermis from the skin and cause blisters. Medical data show that these bruises and blisters do not occur if the vacuum inside the dome is kept below 25-35 mm of mercury for long periods of time. Therefore, the vacuum pump 20 can be regulated to control the vacuum within the dome within this limit. In addition, skin ulceration can occur if excessive pressure is applied to them. Medical data show that a contact pressure of less than 15-20 mm of mercury can be applied indefinitely without such ulceration. However, bruising can occur due to overpressure on the skin at pressures above significant time intervals above this ulcer limit. The preferred embodiment of the present invention was developed with these limits in mind and does not apply a continuous vacuum or constant contact pressure greater than 25-35 mm of mercury.

As a result of evacuating air from the dome, various forces occur within and around the dome. There is a suction force inside the dome 12 designed to equal the vacuum pressure multiplied by the enclosed soft tissue area 30 is. The vacuum or vacuum pressure can also be thought of as negative pressure. The vector sum of the tensile force on the fabric surface area 30 can be called the normal force and is equal to the vacuum pressure multiplied by the normal range 32 the dome opening, ie the area through the periphery 33 is limited. An opposite force is created by the edge 14 exerted on the user to balance the normal force and is the same but opposite the normal force. The contact pressure of the edge 14 against the user is equal to this opposite force divided by the annular edge area 34 , that is, the surface area between the rim and the patient that absorbs the pressure of the dome. Therefore, if the edge area exceeds 34 is configured to be greater than or equal to the normal range 32 at the dome opening, the pressure against the patient's skin is not the magnitude of the vacuum pressure inside the dome 12 , Another physical phenomenon contributes to that Magnifying forces on the soft tissue under the dome 12 at. If the tissue, as in 3 and, as is typically the initial state, only slightly protrudes into the dome, then the surface area 30 just slightly larger than the normal range under the dome 32 at the dome opening. Therefore, because the suction force is directly proportional to the area of the fabric under the dome, the suction force is only slightly larger than the normal force. When enlargement occurs, more tissue pushes into the dome 12 before as in 4 shown with a larger surface area 30 is provided under the dome. Because the surface area 30 is larger under the dome, the suction force generated is increased. As a result, the rate of enlargement increases as treatment progresses.

A special embodiment includes a dome 12 which is designed so that, as in the 1 and 2 shown fits over a human breast. This embodiment includes an edge 14 with a surface area 34 that is larger than the normal range 32 of the dome opening, preventing medical soft tissue complications as long as the pressure within the dome is maintained 12 is properly regulated. The pressure reducing agent 16 are placed below the patient's chest, making the device 10 can be hidden under loose-fitting clothing. As is the case with the general embodiment, the vacuum pump device is in place 16 this embodiment preferably from a vacuum pump 20 with a power source 22 , a pressure sensor 24 and the servomechanism 26 to drive and control the vacuum pump and to control the pressure inside the dome 12 to regulate.

As in 1 shown, this particular embodiment can take the form of a brassiere 40 with two through a hinge 42 spaced domes 12 to have. On the bra 40 can tapes 44 be attached to the bra 40 to keep in place. A sealing ring 46 can also around the edge 14 be involved to improve the patient's well-being and to improve the sealing around the edge. In the preferred embodiment, this sealing ring 46 a silicone gel pad or other soft, compliant type of material. Vaseline or another sealing gel can also be used to supplement or replace the sealing ring. A manual pressure relief valve 48 is on the vacuum pump assembly 16 inserted so that the patient or doctor can vary the pressure below the optimal level so that it is more comfortable. Although two vacuum pump arrangements 16 can be used, depending on each dome 12 To provide various pressures in the domes, the preferred embodiment places the domes in fluid communication with a conduit 50 ,

A second typical embodiment is in 5 shown in the dome 12 is designed to fit over a human penis. As can be seen from this figure, this embodiment comprises essentially the same features as the bra embodiment described above. The principal differences between these embodiments are the arrangement of the dome 12 ' and the edge 14 ' , as well as the positioning of the tapes 44 ' ,

As in 6 shown a dome 52 appropriately over an open wound 54 to be ordered. A pump 56 (including an appropriate controller) draws a vacuum through a communication channel in substantially the same manner as explained above 58 ,

To use the invention, the patient places the dome over the area of desired magnification and adjusts the bands for convenience. Then the patient simply turns on the vacuum pump and the device goes to work. These devices are intended 8th - 12 To be worn hours a day and can be worn during sleep. A remarkable and long-term enlargement should occur after several months. When the desired enlargement has been achieved, the use of the device can be stopped. If additional enlargement is desired, use can continue. Occasional use or use at reduced pressure may also be desirable to maintain the desired magnification.

For alternative applications, such as in a hospital, clinic, or other professional setting, the invention can be applied to the area of desired enlargement or over an open wound or ulcer, and the vacuum pump and controller can be turned on to automatically apply an appropriate one Apply a cure of vacuum and break. As mentioned above, with the invention a vacuum can be built up with a continuous negative pressure and maintained for a longer period of time in order to bring about tissue enlargement and still not cause any damage to the surrounding soft tissue. Alternatively, the invention can provide a "cyclical" regimen that can provide faster tissue enlargement. For example, the vacuum pump can be controlled to develop a pressure as high as 100 mm of mercury for a few minutes and then to returns to a much lower level that is considered safe for long periods of time, such as 15-20 or even 35 mm of mercury, and further testing may find other treatment or use protocols to produce accelerated soft tissue enlargement The present invention should not be construed as being specific The protocol can be regarded as limited, since the inventor believes that various protocols can be learned and used quickly with the present invention.

As can be seen by the experts, there are numerous changes and modifications that can be made to the invention. These changes and modifications are included in the teaching of the disclosure, and it is intended that the invention be achieved only through the Scope of the attached claims limited is.

Claims (13)

Device for promoting soft tissue enlargement, the device comprising a hollow, liquid-tight dome ( 12 ) with sufficient rigidity to withstand vacuum within the dome, pressure reducing means for evacuating air from the dome to provide suction in the dome, and means for regulating pressure within the dome, the dome having a Scope ( 33 ) which surrounds an opening into the interior of the dome and the opening into the interior of the dome has a normal range ( 32 ), the interior of the dome being dimensioned such that it covers the soft tissue to be enlarged and surrounds the soft tissue within the dome, the dome having an edge ( 14 ) that extends around the circumference ( 33 ) the dome extends around and the edge ( 14 ) a contact area ( 34 ) for contacting the skin surrounding the soft tissue to be enlarged in order to support and seal the dome circumference against the skin, the device being characterized in that the edge contact surface area is equal to or larger than the normal area ( 32 ) of the dome opening, so that if a vacuum is sucked into the interior of the dome by actuation of the pressure reducing means, a through the edge ( 14 ) area of the contact surface against the resulting contact pressure exerted on the skin surrounding the soft tissue to be enlarged is smaller than the negative pressure sucked into the dome, thereby minimizing damage to the skin surrounding the soft tissue to be enlarged. Device according to claim 1, characterized by a with the interior of the dome ( 12 ) related vacuum pump ( 20 ) to reduce the pressure inside the dome. Device according to claim 2 , characterized by a with the vacuum pump ( 20 ) connected control device ( 24 . 26 ) to maintain a desired vacuum within the dome. Device according to one of claims 1 to 3, characterized by a on the dome edge ( 14 ) arranged sealing ring ( 46 ) to provide comfort and to seal the dome ( 12 ). Device according to one of claims 2, 3 or 4, characterized by a on the vacuum pump ( 20 ) for setting the pressure within the dome by the manual control provided by the user ( 48 ). Device according to one of the preceding claims, characterized in that the dome ( 12 ) one of a pair of domes ( 12 ), where each dome has a border ( 14 ) with a contact surface area ( 34 ) having; by a band connecting the edges of the pair of domes ( 42 ); and fluid connection means connected between the pair of domes ( 50 ) to equalize the negative pressure within the pair of domes. Apparatus according to claim 6, characterized in that each dome ( 12 ) of the pair of domes is shaped so that it can surround a human breast inside the dome. Device according to claim 3, 4 or 5, characterized in that the dome ( 12 ) one of a pair of domes ( 12 ), where each dome has a border ( 14 ) within a contact area ( 34 ) having; by a band connecting the edges of the pair of domes ( 42 ); in that the vacuum pump ( 20 ) one of a pair of vacuum pumps ( 20 ), each pump communicating with the interior of one of the pair of domes; and in that the control unit ( 24 . 26 ) one of a pair of control devices ( 24 . 26 ), with each controller using one of the pair of pumps ( 20 ) is connected to maintain a desired vacuum in each dome. Device according to one of claims 1 to 5, characterized in that the dome ( 12 ) is shaped so that it can surround a human penis inside the dome. Device according to one of claims 1 to 5, characterized in that the soft tissue to be enlarged is a wound ( 54 ) and that the dome ( 12 ) is shaped so that it can surround the wound inside the dome. Device according to one of the preceding claims, characterized characterized in that the device is portable. Device according to one of the preceding claims, characterized in that the edge contact surface area ( 34 ) is dimensioned sufficiently large to the contact pressure of the edge limit the soft tissue surrounding the soft tissue to be enlarged to less than 20 mm of mercury when the negative pressure is created in the dome. Device according to claim 12, characterized in that the vacuum is between 25 mm and 35 mm of mercury.